CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 657 enrolled
Drug / intervention
New Parent Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04477577
NCT04477577N/ACompleted

First Heroes: Engaging Fathers in the First 1000 Days

Massachusetts General Hospital·interventional·Posted Jul 20, 2020·Updated May 11, 2026

In Brief

A clinical study evaluating New Parent Intervention and Safety Control for Obesity, Childhood and 6 related conditions. Completed, enrolled 657 participants across 1 site.

Detailed Summary

The First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations. This study is a two-arm, randomized controlled trial recruiting from Massachusetts General Hospital (MGH) obstetrics practices. This study will enroll 250 father-mother dyads in the second trimester of pregnancy and intervene through their offspring's 1-year birthday. Each mother-father dyad participating will be randomly assigned to one of two arms: 1. Obstetric and Pediatric Standard of Care + New Parent Engagement Intervention Arm or; 2. Obstetric and Pediatric Standard of Care + Safety Control Arm.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 20, 2020
Enrollment StartAug 4, 2020
Primary CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.0 years ago

Interventions

New Parent Interventionbehavioral

This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach.

Safety Controlbehavioral

This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials.